NCT00775775

Brief Summary

This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

6.6 years

First QC Date

October 16, 2008

Last Update Submit

October 2, 2009

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population

    1 year

Secondary Outcomes (1)

  • To study the relationship between fatigue and endocrine abnormalities

    1 year

Study Arms (1)

TBI

Patients with moderate to severe TBI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will consist of 50 participants taken from the outpatient brain injury program at Kessler.

You may qualify if:

  • Having moderate to severe TBI at least 3 months prior to enrollment. This can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury
  • Be between the ages of 18 and 70 years

You may not qualify if:

  • History of prior TBI, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded.
  • Pregnant, nursing, or planning pregnancy during the study period.
  • Dementia
  • Other neurological conditions which are associated with aging and known to cause fatigue (e.g. Parkinson's Disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Anthony Lequerica, Ph.D.

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Lequerica, Ph.D.

CONTACT

973-324-3551alequerica@kesslerfoundation.net

Alexandria Muench

CONTACT

973-324-3540amuench@kesslerfoundation.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 20, 2008

Study Start

May 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations

US(1)